The FDA announced MDUFA IV user fees for fiscal 2019 with modest increases that will go into effect on Oct.1.
For pre-market applications, product development protocols or biologics license applications, the standard fee will be $322,147, up from $310,764 for fiscal 2018. Small businesses will pay $80,537 compared with $77,691 in fiscal 2018. The same fees apply for premarket reports and efficacy supplements.
The standard and small business fees for 510(k) premarket notification submissions will be $10,953 and $2,738, respectively, while de novo classification requests will be $96,644, with a $24,161 fee for small businesses.